Security and Incident Response, U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Washington, DC 20555. The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being canceled. The licensee shall retain a copy of the notice as a record for three years.
AUTHORITY NOTE:Promulgated in accordance with R.S. 30:2104.B and 2113.
HISTORICAL NOTE:Promulgated by the Department of Environmental Quality, Nuclear Energy Division, LR 13:569 (October 1987), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:1269 (June 2000), LR 26:2602 (November 2000), amended by the Office of Environmental Assessment, LR 30:2029 (September 2004), amended by the Office of the Secretary, Legal Affairs Division, LR 31:2537 (October 2005), LR 33:2190 (October 2007), LR 34:2111 (October 2008).
A.Quality Assurance Requirements
1.This Section describes quality assurance requirements applying to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. As used in this Section, "quality assurance" comprises all those planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quality of the material or component in accordance with predetermined requirements. The licensee, certificate holder, and applicant for a CoC are responsible for the quality assurance requirements as they apply to design, fabrication, testing, and modification of packaging. Each licensee is responsible for the quality assurance provision that applies to its use of a packaging for the shipment of licensed material subject to the quality assurance requirements of this Section.
2.Each licensee, certificate holder, and applicant for a CoC shall establish, maintain, and execute a quality assurance program that satisfies each of the applicable criteria of this Section and that satisfies any specific provisions that are applicable to the licensee's activities, including procurement of packaging. The licensee, certificate holder, and applicant for a CoC shall execute the applicable criteria in a graded approach to an extent that is commensurate with the quality assurance requirement's importance to safety.
3.Before using any package for the shipment of licensed material subject to this Section, each licensee shall obtain U.S. NRC approval of its quality assurance program. Using an appropriate method listed in 10 CFR 71.1(a), each licensee shall file a description of its quality assurance program, including a discussion of which requirements of this Section are applicable and how they will be satisfied, by submitting the description to the Document Control Desk, Director, Spent Fuel Project Office, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Washington, DC 20555.
4.A U.S. NRC approved quality assurance program that satisfies the applicable criteria of 10 CFR Part 71,
Subpart H, 10 CFR Part 50, Appendix B, or 10 CFR Part 72, Subpart G, and that is established, maintained, and executed regarding transport packages, will be accepted as satisfying the requirements of Paragraph A.2 of this Section. Before first use, the licensee, certificate holder, and applicant for a CoC shall notify the U.S. NRC, in accordance with 10 CFR 71.1, of its intent to apply its previously-approved Subpart H, Appendix B, or Subpart G quality assurance program to transportation activities. The licensee, certificate holder, and applicant for a CoC shall identify the program by date of submittal to the U.S. NRC, Docket Number, and date of U.S. NRC approval.
5.A program for transport container inspection and maintenance limited to radiographic exposure devices, source changers, or packages transporting these devices, and meeting the requirements of LAC 33:XV.547.B, is deemed to satisfy the requirements of LAC 33:XV.1507.B and Paragraph A.2 of this Section.
B.Quality Assurance Organization
1.The licensee (or anyone who designs, fabricates, assembles, and tests the package before the package approval is issued), certificate holder, and applicant for a CoC shall be responsible for the establishment and execution of the quality assurance program. The licensee, certificate holder, and applicant for a CoC may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part of the quality assurance program, but shall retain responsibility for the program. The delegatable activities include performing the functions associated with attaining quality objectives and the quality assurance functions.
2.The quality assurance functions consist of assuring that an appropriate quality assurance program is established and effectively executed, and verifying, by procedures such as checking, auditing, and inspection, that activities affecting the functions that are important to safety have been correctly performed.
3.The person or organization performing quality assurance functions must be given sufficient authority and organizational freedom to:
a.identify problems with quality;
b.initiate, recommend, or provide solutions; and
c.verify implementation of solutions.
4.A person or organization performing quality assurance functions must report to a management level that assures that the required authority and organizational freedom, including sufficient independence from cost and schedule factors, when opposed to safety considerations, are provided.
5.Because of the many variables involved, such as the number of personnel, the type of activity being performed, and the location(s) where activities are performed, the organizational structure for executing the quality assurance program may take various forms, provided that persons and organizations assigned the quality assurance functions have the required authority and organizational freedom.
6.Irrespective of the organizational structure, any individual assigned the responsibility for assuring effective execution of any portion of the quality assurance program, at any location where activities subject to this Section are being performed, must have direct access to the levels of
Louisiana Register Vol. 34, No. 10 October 20, 2008